Harvard Pilgrim Wins Contract From FDA

The company said that the Sentinel System, once operational, is expected to bolster the FDA’s efforts in monitoring product safety. Sentinel will provide FDA with the ability to analyse information collected during the course of routine health care, such as data from electronic health record systems, administrative and insurance claims databases and medical registries.

The one-year contract with Harvard Pilgrim, based in Wellesley, includes four renewable years for a total of $72m. As per the terms of the contract, Harvard Pilgrim will establish a coordinating center that will operate as a scaled down version of the Sentinel System.

The center, or ‘mini-Sentinel,’ will identify appropriate databases, develop a scientific framework for obtaining real-time data, and ensure data quality. To protect personal information, only summary results will be sent to the coordinating center. The data itself will remain within its database.

The Sentinel System fulfills some requirements of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which include provisions calling for the development of such a system.

Janet Woodcock, director of the center for drug evaluation and research at FDA, said: “The FDA has been doing the groundwork for a nationwide Sentinel System. Once operational, the Sentinel System will help us find answers to important drug safety questions, to stronger safeguards for public health, while still protecting the privacy and security of individual health information.”